State Oversight of Drug Compounding

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1 Feb A report from The Pew Charitable Trusts and the National Association of Boards of Pharmacy State Oversight of Drug Compounding Major progress since 05, but opportunities remain to better protect patients

2 Contents Overview 4 Background 5 Current landscape of sterile compounding oversight Quality standards 5 Challenges for states requiring USP Chapter <797> 7 What the upcoming revision of Chapter <797> means for states 7 Compounding without prescriptions 9 Limitations on sterile office stock compounding Nonsterile office stock compounding Outsourcing facilities In-state pharmacy inspections 3 Inspector education and training 4 Out-of-state pharmacies 4 Quality standards for nonresident pharmacies 4 Inspections of nonresident pharmacies 5 6 Recommendations 6 Conclusion 7 Appendix A: Methodology and characteristics of participating states 9 Appendix B: Questionnaire 4 Appendix C: Complete tables of state oversight of sterile compounding 79 Endnotes

3 The Pew Charitable Trusts Susan K. Urahn, executive vice president and chief program officer Allan Coukell, senior director, health programs Elizabeth Jungman, director, public health programs National Association of Boards of Pharmacy Eileen Lewalski, senior manager, professional affairs Scotti Russell, manager, government affairs External reviewers The report benefited from the insights and expertise of three external reviewers: Jane Axelrad, principal, Axelrad Solutions LLC; Eric Kastango, CEO, Clinical IQ LLC; and Patricia Kienle, director, accreditation and medication safety, Cardinal Health Inc. Any opinions and conclusions expressed herein are those of The Pew Charitable Trusts and National Association of Boards of Pharmacy, and do not necessarily represent the views of the above individuals. Acknowledgments Pew would like to thank the following current and former program staff for their role in this research: Erin Hass, Karen Kavanaugh, Danita Moses, Kathy Pham, Kimberly Smith, Emily Snyder, and Glenn Wright. We would also like to thank the following Pew staff for their contributions: Casey Ehrlich, Elizabeth Hughes, and Alan van der Hilst for their research review and support; Sara Brinda, Kimberly Burge, Matt Mulkey, and Liz Visser for their editorial input; and Erin McNally for her work preparing this report for publication. Finally, we would like to thank our study participants. Contact: Sara Brinda, senior associate, communications Project website: pewtrusts.org/drugsafety The Pew Charitable Trusts is driven by the power of knowledge to solve today s most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and invigorate civic life.

4 Overview More than five years have passed since contaminated injections compounded at a single pharmacy caused 76 deaths and 778 illnesses in a nationwide outbreak of fungal meningitis, a tragedy that made clear that the complex, technical practice of drug compounding was not subject to a level of oversight appropriate to its potential risks to patients. Since then, state and federal officials have been re-examining the laws and regulations governing compounding, and working to strengthen them. Compounding is the creation of medications tailored to patients whose clinical needs cannot be met by U.S. Food and Drug Administration-approved products. Compounded medications pose a higher level of risk to patients than FDA-approved drugs because they have not been tested for safety and efficacy, have not gone through an approval process, and are typically not made under the same quality standards as approved products are. The Pew Charitable Trusts drug safety project has identified more than 50 reported compounding errors or potential errors from 00 to 07 linked to,7 adverse events undesirable experiences associated with the use of a medical product including 99 deaths. And because many such events may go unreported, this number is likely to be an underestimation. Scrutiny of compounding policies following the meningitis outbreak in 0 brought to light weaknesses in state and federal oversight of these potentially risky drugs, prompting reforms at both levels. In November 03, Congress passed and President Barack Obama signed into law the bipartisan Drug Quality and Security Act (DQSA), which established clear lines of oversight accountability for two categories of businesses that can compound drugs: States oversee compounders of patient-specific drugs. They have primary jurisdiction over traditional compounders, who tailor medications to individual patients and include pharmacists practicing in a variety of settings, including community pharmacies and hospitals, as well as physicians who create medications for administration to their patients. These traditional compounders were placed under state jurisdiction in 997 after Congress introduced new federal policy on compounding as part of the Food and Drug Administration Modernization Act, adding Section 503A to the Federal Food, Drug, and Cosmetic Act (FDCA), and remain so under the DQSA. Both compounding pharmacies and physicians who compound drugs in their offices can be considered traditional compounders, but this report focused on oversight of pharmacies. FDA oversees drugs compounded without an individual patient in mind, known as non-patient-specific compounded drugs. FDA is the primary regulator of outsourcing facilities, which can produce office stock (bulk supplies of non-patient-specific compounded drugs for hospitals, doctors offices, and other health care facilities), and are regulated under Section 503B of the FDCA. The vast majority of compounding is patient-specific; as such, it remained under states jurisdiction in the federal law. In response to both the outbreak and the subsequent federal law that clarified these regulatory responsibilities, many states also began developing strategies to strengthen their own drug compounding oversight. As state officials were seeking to determine which reforms would help them oversee the industry most effectively, Pew convened an advisory committee of state pharmacy regulators and other experts to identify best practices (see the Best Practices section below), which were published in its 06 report Best Practices for State Oversight of Drug Compounding.

5 In 06 Pew also published the report National Assessment of State Oversight of Sterile Drug Compounding, an evaluation of the national landscape of state policies on compounding of sterile drugs, based on data collected in 05. The current report provides a targeted update of the prior assessment, focusing on state alignment with three key best practices: Application of U.S. Pharmacopeial Convention (USP) quality standards on sterile compounding. Harmonization with federal law on compounding without prescriptions. Annual inspections of facilities that perform sterile compounding. This assessment collected data from publicly available sources, which were then verified by the boards of pharmacy in 43 states and the District of Columbia, and through interviews with representatives from four randomly selected boards. State officials have strengthened sterile compounding oversight laws and rules since the 05 assessment. The vast majority of states now conform to best practices in two of the three key areas: 3 state boards of pharmacy require traditional pharmacies that compound sterile drugs for humans to be in full compliance with the widely recognized quality standards established by the USP in its General Chapter <797>, Pharmaceutical Compounding Sterile Preparations. An additional states have strong requirements on sterile compounding practice, which 0 of them characterize as equivalent to or stricter than Chapter <797>, even if some elements are less specific. An additional four states have pending policy changes that, if passed, would require full compliance with <797> or other strong quality standards. In 05, just 6 states required<797> or equivalent quality standards for sterile compounding. 39 states and the District of Columbia prohibit traditional pharmacies from compounding for sterile office stock for human use through their laws, regulations, or state guidance, or by advising compounders to follow the DQSA. However, states have office stock policies (many predating the federal law) that are not aligned with federal statute. In 05, representatives from nearly two-thirds of state boards of pharmacy that responded to the Pew assessment allowed traditional compounding pharmacies to produce drugs without prescriptions to at least some extent. It appears that states may be inspecting traditional pharmacies that do sterile compounding for humans less frequently now than in 05. Then, 6 states and the District conducted routine inspections at least annually for in-state pharmacies that perform sterile compounding; today, just states and the District do so. Interviews with state officials underscore the need for more financial resources and inspection capacity. The significant progress in adopting USP Chapter <797> quality standards and aligning with federal law on compounding without prescriptions suggests a key opportunity for jurisdictions that have not yet adopted these best practices. Improvements in rigor and frequency of inspection of facilities that perform sterile compounding will require resources, but interim measures such as harmonizing inspection forms and processes among states may allow for optimal use of existing capacity and enhance efficiencies. While the majority of states have taken action to strengthen sterile compounding oversight policies since the outbreak, it is essential to follow through with strong implementation and enforcement of these laws and rules including the federal DQSA. This report is intended to highlight the significant progress on public health policy that has occurred and to identify the most fruitful opportunities for action to help ensure a safe supply of compounded drugs. This remains a period of flux for drug compounding oversight: A number of states have pending policy changes, and implementation of the federal DQSA is ongoing. This continuing progress is one key finding of this study.

6 Best Practices In 04, The Pew Charitable Trusts convened an advisory committee of state regulators and other experts to examine state oversight of compounding and develop best practices. The panel reviewed several regulatory topics, including inspections of compounding pharmacies, requirements for quality, expectations for pharmacist training, and the practice of compounding without a prescription. The committee also discussed how states should harmonize these requirements with federal law and regulations, particularly on issues such as definition and recognition of the outsourcing facility category created by the DQSA. Based on the advisory committee process, Pew produced a report in 06 that identified the practices that are most meaningful to patient safety and the most achievable while recognizing that state funding may limit oversight systems. The best practices provide a resource to state regulators, policymakers, and stakeholders who are reviewing oversight practices, and they also support greater harmonization across states which because of the interstate movement of compounded drugs can help ensure consistent oversight and help discourage businesses from locating in states with less rigorous regulations. The best practices include: Application of U.S. Pharmacopeial Convention (USP) quality standards on compounding. Training in sterile compounding for pharmacists who perform or supervise it. Annual inspections of facilities that perform sterile compounding. State mechanisms, such as separate licensure, to identify and apply specific standards to facilities performing sterile compounding. Recognition and definition of outsourcing facilities in a manner aligned with federal law. Harmonization of policies on compounding without prescriptions with federal law. Meaningful oversight of sterile compounding that occurs in physicians offices. Mechanisms to track the compounding activities conducted by pharmacies within the state. Whenever the current report refers to best practice recommendations, it means the practices described in detail in Pew s 06 report Best Practices for State Oversight of Drug Compounding. 3

7 Background Pharmaceutical compounding is the creation of medications that are tailored to the requirements of patients whose clinical needs cannot be met by FDA-approved products. Like other licensed health care practices, compounding is primarily regulated by the states. Compounded medicines differ from FDA-approved products, which have earned that classification by undergoing a formal drug approval process to demonstrate that their therapeutic benefits outweigh their risks and that they work as intended. Compounding is an important component of health care in specific circumstances. This process is used, for example, when a child needs a liquid version of a medicine that is approved only in tablet form; when a patient who cannot eat and digest normally must be fed intravenously with a customized mixture of nutrients; or when a patient requires a preservative-free formulation of a sterile drug. Compounded products pose a higher level of risk to patients than approved products because they have not been tested for safety and efficacy. They are also typically not prepared under the same quality standards requirements for how drugs are manufactured and stored to prevent contamination or other potentially dangerous problems. Meaningful quality standards are important for all forms of compounded drugs, including tablets, capsules, syrups, and topical creams, but rigorous standards are most critical for drugs that are injected or infused into the body and therefore must be sterile to minimize the risk of infection. Compounding is as old as the practice of pharmacy itself, and the compounding of sterile injectables and intravenous infusion products by a pharmacist or other practitioner emerged as a practice in the early 0th century, primarily in hospital settings. As the complexity of sterile preparations increased and demand grew, outsourced sterile compounding, conducted off site by a third party, became a viable commercial enterprise. Dramatic expansion of the outsourced compounding sector in the years before the 0-3 fungal meningitis outbreak resulted in facilities whose production volumes were in some cases on a scale closer to conventional manufacturing by pharmaceutical companies than traditional compounding done by pharmacists, and it was unclear which regulators were responsible for overseeing these operations. In general, states regulate pharmacists and licensed pharmacies, while the federal government regulates conventional manufacturing but the compounding of stock supplies of medications fell into a gray area between these oversight systems. A series of conflicting judicial opinions in 00, 00, and 008 led to further confusion about which specific compounding activities were subject to federal oversight and which were the domain of states. Moreover, some states were not prepared to regulate this industry appropriately or had too few resources to do so meaningfully. Thus, this complex, technical practice was not consistently overseen at a level commensurate with its potential risks to patients. Those were the conditions when the fungal meningitis outbreak occurred after one pharmacy shipped contaminated injectable medications across the country, killing dozens and injuring hundreds more. While this outbreak is the most extensive known example of harm to patients from compounded drugs, many other cases of serious illness, injury, and death associated with such medications have occurred. In the aftermath of the outbreak, federal and state policymakers, as well as other groups, moved to examine the issues underlying drug compounding and to identify solutions to the systemic shortcomings that allowed the outbreak to occur. Problems highlighted included ways in which state oversight needed to improve, and many state boards of pharmacy responded by re-examining and strengthening their drug compounding oversight laws and rules. Meanwhile, at the federal level, the DQSA was signed into law in November 03. 4

8 The DQSA clarified the distinction between two types of compounders: Pharmacies or physicians (collectively called traditional compounders in this report) that prepare drugs pursuant to individual prescriptions to meet specific patient needs. These compounders are regulated under Section 503A of the FDCA. Companies selling supplies of compounded drugs without patient-specific prescriptions. They are now regulated as part of a new outsourcing facility sector under the FDCA s Section 503B and are required to meet accordingly stricter quality controls. The DQSA clarified that FDA has primary oversight of the outsourcing facility compounding sector, while states are primarily responsible for regulating the practice of pharmacy, including compounding in traditional pharmacies to fill individual patient prescriptions. (Section 503A of the FDCA authorizes compounding by pharmacists and physicians. This report focuses on compounding as a pharmacy practice, and physician compounding is addressed only briefly, in the Physician s Office or Clinic Compounding section below. Compounding by other types of practitioners is beyond the scope of this research.) Current landscape of sterile compounding oversight Quality standards Conforming to scientifically sound standards, such as those established by USP, is critical to preventing contamination, especially for sterile compounding. Deficiencies in sterile compounding practices can cause patient harm and death. Best practice recommendations include state application of USP quality standards on compounding. For compounding sterile preparations, the widely recognized quality standards in USP Chapter <797> describe specific procedures, conditions, and other requirements that, when followed, are designed to prevent patient harm resulting from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. Specifically, Chapter <797> describes practices such as appropriate sterile garbing (putting on protective gear such as face masks, shoe covers, and eye shields), cleaning procedures, environmental controls such as airflow, monitoring practices to detect and remediate unacceptable levels of contaminants in the air and on equipment and surfaces, and tests and checks to ensure product quality before drugs are released. Our study found that 3 state boards of pharmacy require traditional pharmacies that compound sterile drugs for humans to be in full compliance with Chapter <797>. An additional states have strong standards for sterile compounding practice, which 0 states characterize as equivalent to or stricter than <797>, even if some elements are less specific. Six states and the District of Columbia require other compounding quality standards. In Pennsylvania, for example, traditional pharmacies must adhere to compounding quality standards, though the standards do not specify minimum equipment or facility requirements for compounding, a key component of Chapter <797>. 3 As of this writing, just one state, Kansas, does not impose any particular compounding quality standards. However, its board of pharmacy has been directed by statute to adopt rules and regulations governing proper compounding practices and distribution of compounded drugs by pharmacists and pharmacies. 4 Kansas and three other states have pending policy changes that, if passed, would require full compliance with <797> or other strong quality standards. 5

9 Figure Compliance With Sterile Compounding Standards 3 states require full compliance with USP Chapter <797> quality standards WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK TX MN WI IA IL MO AR MS LA NY MI PA OH IN WV VA KY NC TN SC AL GA ME VT NH MA RI CT NJ DE FL MD AK DC HI Require full compliance with USP <797> Require other quality standards Require compliance with strong requirements on sterile compounding practice, including the 0 states reporting standards equivalent to or stricter than USP Chapter <797>, even if some elements were less specific. Does not require quality standards 08 The Pew Charitable Trusts The widespread adoption of strong quality standards represents significant progress made by states in recent years. The 05 assessment found that 6 states mandated Chapter <797> or equivalent quality standards for sterile compounding. (We caution against direct comparisons between these numbers, because there were slight methodological differences between how this question was assessed in each report. For the earlier report, based on data from 05 and published in 06, researchers asked boards of pharmacy whether their state mandated <797> or equivalent quality standards for sterile compounding, but that questionnaire, unlike the present study, did not explicitly define what could be considered equivalent quality standards. The current study s methodology was slightly different: First, a licensed pharmacist on Pew s staff compared the state s requirements to USP s to determine whether the state standards for sterile compounding were as strong or stronger than the correlating requirements of <797>, even if some elements were less specific. States were then asked to verify whether Pew s determination was accurate.) Despite the differences in research methodology between the two assessments, it is evident that policy shifts have occurred in many states. 6

10 Challenges for states requiring USP Chapter <797> Chapter <797> describes conditions and procedures that, if followed while compounding sterile drugs, help ensure the drugs quality and prevent them from harming patients. Although the chapter is incorporated into or referenced by many states laws and regulations, state boards of pharmacy have cited challenges in using it as an enforceable set of rules. For example, the standards generally descriptive language and use of the words should and shall can lead to ambiguity as to what is required versus what is recommended. 5 To mitigate any confusion, some states have created tools that help pharmacies determine whether they are in compliance with <797>. In Washington state, for instance, the Pharmacy Quality Assurance Commission created a Sterile Compounding [USP <797>] Self-Assessment Compliance Checklist that includes the reported principal competencies, conditions, practices, and quality assurance that are required ( shalls ) in U.S. Pharmacopeial (USP) <797> and is designed to be a tool to guide and aid you [compounders] to assess your compliance with USP <797>. 6 Enforcement challenges result not only from the way Chapter <797> is written, but also because it is constantly updated to reflect new research and evidence-based best practices, respond to stakeholder input, and clarify aspects of the standards. Recognizing this, some states have rewritten (or are rewriting) their regulations to exceed the requirements of the current version of <797>. For example, the Massachusetts Board of Registration in Pharmacy reports that a pending state regulation would clarify certain <797> standards, provide greater instruction for state-licensed compounders, and in some cases go above and beyond <797> standards. In New Jersey, regulations fully comply with the intent of the chapter, according to the state Board of Pharmacy, which also reports that, in some cases, its quality standards are more stringent than <797>. For instance, the board requires pharmacies to report any test results indicating possible contaminants in or around the compounding facility and any confirmed incidents of product contamination to the board within 48 hours, while the current version of <797> simply requires compounders to create an actionable plan in such instances. What the upcoming revision of USP Chapter <797> means for states USP is revising its standards for sterile compounding. A draft published in September 05 received more than 8,000 comments from,500 stakeholders. Because USP received so many comments, the next draft of the revised edition of <797> will be open for another public comment period before it is finalized. In September 07, the USP Compounding Expert Committee, which is charged with creating and revising compounding-related chapters and developing compounded preparation monographs, announced that it anticipates this second public comment period to open in September 08. The committee expects that the revised <797> will become official in December 09, though USP may allow more time for adoption of certain components of the new standards. 7 Some states will immediately require full compliance with the updated <797> because their pharmacy laws or rules require compliance with whatever version of <797> is current at the time. For example, New Hampshire administrative rules state that [t]he board shall require all compounders engaging in compounding in all situations to adhere to and comply with the current edition of the United States Pharmacopeia including but not limited to Chapters 795 (USP 795) and 797 (USP 797), following those guidelines that apply to their practice setting. 8 (Chapter <795> contains quality standards for the preparation of nonsterile compounded medications.) Other states that require full compliance with a specific version of Chapter <797> will need to make legislative or regulatory changes to mandate compliance with the revised version when it is finished. For example, Wyoming recently passed regulations that require full compliance with <797> as [it existed] on May, 07-July 3, 07 including amendments adopted by USP as of that date, 9 and therefore would need to revise these regulations to require full compliance with the updated <797>. 7

11 Pharmacist Education and Training State rules for pharmacist education and training on compounding vary. Some states, such as New York and Georgia, require pharmacists to pass a hands-on practical examination before becoming licensed; Massachusetts has stringent continuing education requirements. As previously mentioned, some state boards of pharmacy, such as Washington s, developed educational tools to assist pharmacies in complying with USP Chapter <797>. However, most pharmacists obtain their sterile compounding training and experience on the job. The best practice recommendation published in 06 is that states require training in sterile compounding for pharmacists who perform or supervise it. To be effective, such training must include classroom and practical components, and must cover core elements of <797>. 0 Physician s Office or Clinic Compounding Sterile compounding typically occurs in pharmacies but may also take place in doctors offices or clinics. Some research suggests that the frequency of contamination of parenteral drug preparations (a category that includes drugs administered through higher-risk routes, such as intravenously or through injection) is higher in clinical environments than in controlled pharmacy environments. Serious adverse events occurring as a result of physicians office compounding include a case in 06 in which 7 people developed fungal bloodstream infections after they received contaminated compounded intravenous medications that were prepared at an outpatient oncology clinic in New York. States generally do not track physician compounding, so the extent of the practice is unclear. Typically, compounding that occurs in doctors offices is subject to oversight by state boards of medicine rather than pharmacy boards. While a few states have regulations governing compounding in those settings, most do not. 3 The best practice recommendation published in 06 is that states develop meaningful oversight for compounding in physicians practices, which includes adopting the same quality standards as other compounding facilities to ensure patient safety. The advisory committee of state regulators and other experts recommended that this issue also be addressed through collaboration between the Federation of State Medical Boards and the National Association of Boards of Pharmacy. 4 8

12 Compounding without prescriptions State-licensed compounders who seek to produce drugs that qualify for the exemptions under Section 503A of the federal FDCA are prohibited from compounding drugs for human use without a prescription outside of the limited quantities of anticipatory compounding permitted under Section 503A and FDA s prescription requirement guidance for industry. (Anticipatory compounding occurs in circumstances where a pharmacist can anticipate receiving repeated prescriptions for the same compounded drug for instance, if the pharmacist has a relationship with a practitioner who commonly prescribes a particular product and can compound a supply of that drug in advance of that need and dispense or distribute it as the prescription orders come in.) Dispensing supplies of drugs without a prescription for office use (also called office stock) is allowed only for a facility that has registered with FDA as an outsourcing facility under Section 503B of the FDCA, which must meet Current Good Manufacturing Practice (CGMP) standards, which are similar to those that conventional manufacturers must meet. The majority of states also require outsourcing facilities to be separately licensed or registered. Best practice recommendations include harmonizing state policies on compounding without prescriptions with federal law, and recognizing and defining outsourcing facilities in a manner aligned with federal law. 5 Section 503A created a regulatory framework for pharmacists to produce medicines for specific patients without having to go through the drug approval process to demonstrate safety and effectiveness, while section 503B addressed the need of hospitals and other health care providers to attain bulk supplies of drugs that are otherwise not available to meet patients medical needs. The DQSA was explicitly written to ensure that sterile drugs that were being produced without a prescription would be held to more robust quality standards than those that apply to traditional compounding. FDA finalized its prescription requirement guidance for industry in December 06, an important step toward fully implementing the DQSA. The document clarifies the law s requirement that traditional compounders dispense or distribute compounded products only upon receipt of a valid prescription. Because outsourcing facilities can produce and distribute drugs without a prescription, while traditional compounders cannot, FDA calls the prescription requirement a critical mechanism for distinguishing traditional compounders from drugmakers that must comply with higher manufacturing standards. 6 Most states prohibit traditional pharmacies from compounding for office stock, but some states have office stock policies (many predating the federal law) that are not aligned with federal statute. This study found that 39 states and the District of Columbia prohibit traditional pharmacies from compounding sterile drugs for humans in the absence of patient-specific prescriptions outside of anticipatory compounding permitted under FDA s prescription requirement guidance for industry through various mechanisms: state laws or regulations (30 states and the District), state guidance (five states), or advice to compounders to follow the more restrictive federal law (four states). All of the states that allow traditional pharmacies to compound sterile office stock for humans place limitations on this practice. 9

13 Figure Restrictions on Sterile Office Stock Compounding for Humans 39 states and the District of Columbia prohibit the practice through laws and other measures WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK TX MN WI IA IL MO AR MS LA NY MI PA OH IN WV VA KY NC TN SC AL GA ME VT NH MA RI CT NJ DE FL MD AK DC HI Prohibit sterile office stock compounding for humans through their laws or regulations, state guidance, or by advising compounders to follow the more restrictive federal law Allow sterile office stock compounding for humans with limitations 08 The Pew Charitable Trusts State boards of pharmacy have been leaders in protecting patient safety by strengthening sterile compounding oversight policies to help ensure a safe supply of compounded medications. Pew s 05 state-by-state assessment found that representatives from nearly two-thirds of the boards that responded allowed traditional compounding pharmacies to produce drugs without prescriptions, at least to some extent. That assessment categorized anticipatory compounding as a state limitation on office stock compounding and noted that states appeared in some cases to conflate anticipatory compounding with compounding a supply of a drug without a prescription to be stocked by a doctor s office or clinic. Other limitations on office stock that states identified in the earlier assessment included volume restrictions, limiting the practice to veterinary use, and confining the practice to outsourcing facilities. 0

14 In the current study, 39 states and the District of Columbia do not permit traditional pharmacies to compound sterile drugs for humans in the absence of patient-specific prescriptions outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry. (In the present assessment, the research team verified with states whether they allow traditional pharmacies to compound sterile drugs for humans in the absence of patient-specific prescriptions outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry.) Under the DQSA, 503B outsourcing facilities are now the only entities allowed to distribute compounded drugs without prescriptions in exchange for submitting to more stringent oversight. Some states, such as New York, prohibited traditional pharmacies from doing sterile office stock compounding for human use before passage of the DQSA. Others moved to prohibit the practice in light of the DQSA and FDA s prescription requirement guidance for industry. For example, New Jersey requires pharmacies to comply with the FDCA (the law that the DQSA amended) and therefore prohibits traditional pharmacies from compounding sterile drugs for humans in the absence of patient-specific prescriptions. However, the New Jersey Board of Pharmacy is currently rewriting its rules to clarify this regulation. Still other states with laws that permit compounding for office stock nevertheless advise the pharmacies they oversee that federal law prohibiting the practice prevails. Limitations on sterile office stock compounding Although the federal DQSA prohibits traditional compounders from compounding drugs for humans in the absence of patient-specific prescriptions (outside of anticipatory compounding), state boards of pharmacy allow the practice. In those states, traditional compounders that comply with state requirements may nevertheless be in conflict with federal law. The best practices recommendation is that states harmonize their prescription requirements with federal law. States that choose not to do so may create a confusing regulatory environment for traditional compounders in their state and risk that pharmacies that comply with state compounding requirements are nevertheless subject to federal enforcement. However, all states that permit compounding sterile drugs for office stock place limitations on it, the most common being that traditional pharmacies may prepare office stock only in limited quantities and may prepare it only for physicians to administer in their offices. One state restricts the distribution of office stock to practitioners in the state, and two states allow traditional pharmacies to produce office stock only if they have a special agreement approved by the board of pharmacy. Four states place more than one of these limitations on office stock compounding. Whether these constraints are meaningful will be affected by state interpretation and enforcement. For example, limited quantities is not always defined, which may create challenges for compliance and enforcement. And because some products are always physician-administered, requiring that any office stock be administered by a physician may not meaningfully affect the volume of office stock of such products that a compounder could produce. States that allow traditional pharmacies to compound sterile drugs for humans without patient-specific prescriptions (outside of anticipatory compounding) blur the clear line the DQSA drew between traditional pharmacies and outsourcing facilities. Even states that place strict limitations on the practice create a gray area with unclear lines of accountability for compounders one of the problems that led to the meningitis outbreak and that the DQSA solved.

15 Despite this concern, the California State Board of Pharmacy believes it serves public health to allow traditional pharmacies to compound office stock under specific limitations because the state considers it safer for pharmacists overseen by the board to compound office-use drugs than for prescribers (or prescribers personnel) to do so in their offices. The concern is that a prohibition on office stock could drive compounding into physicians offices. California draws its own line between traditional pharmacies and outsourcing facilities: The latter are not allowed to compound patient-specific prescriptions. For California, and potentially other states that may permit office stock for the same reasons, enhanced oversight of compounding in prescribers offices could make it more feasible for the state to adopt the best practice recommendation published in 06 to follow federal law requiring prescriptions. Nonsterile office stock compounding While 39 states and the District of Columbia prohibit traditional pharmacies from compounding sterile drugs for humans in the absence of patient-specific prescriptions, five fewer jurisdictions (34 states and the District of Columbia) apply that same prescription requirement to nonsterile compounding. Nonsterile products pose risks that can result in serious patient harm, as was tragically illustrated in 009, when a patient in North Carolina died after taking compounded capsules of thyroid medication that were 8 times stronger than ordered, 7 and years earlier when two patients died after topical anesthetics they received were too potent. 8 As with other state regulations of compounded products, this is a time of change, and states may still be moving toward prohibiting nonsterile office stock compounding for humans. For example, Oklahoma removed regulations in 07 that allow nonsterile office stock compounding. Oklahoma pharmacists are expected to comply with federal law on office use compounding. It is worth noting that outsourcing facilities the only entities permitted by federal law to dispense or distribute compounded drugs without patient-specific prescriptions are required to compound at least some sterile drugs. At present, there is no legal way for an outsourcing facility to produce only nonsterile drugs, potentially creating problems when office stock of such products is necessary. Outsourcing facilities FDA has primary oversight of the outsourcing facility sector. However, many states also separately license or register outsourcing facilities. Our study found that 38 states license or register facilities that also register with FDA under the federal outsourcing facility category. Federal law neither prohibits nor requires state pharmacy licensure for outsourcing facilities, and until recently there was no statutory or other guidance to states on how they should oversee outsourcing facilities. In 06, FDA developed preliminary recommendations for state licensure of outsourcing facilities, which includes the recommendation that states create a separate state licensure category specific to outsourcing facilities. 9 States are not required to follow this recommendation, and their approaches to recognizing this category of compounders vary. Among the 38 states that license or register 503B facilities, the most common practice is to license or register them as outsourcing facilities. Other states license or register these facilities as manufacturers or wholesale distributers. Colorado registers in-state outsourcing facilities as manufacturers but out-of-state outsourcing facilities as wholesalers. New Hampshire issues permits for outsourcing facilities in a category it calls bulk sterile and nonsterile compounders, and Mississippi issues a sterile product outsourcing permit.

16 States also vary on whether they allow a facility to act as both a traditional compounder and an outsourcing facility. Some states allow outsourcing facilities to also compound patient-specific prescriptions as long as all of the facility s compounding adheres to CGMP standards, while at least one state prohibits outsourcing facilities from compounding any patient-specific prescriptions. At least one state requires outsourcing facilities to register as pharmacies even if they do not compound patient-specific prescriptions, at least one state prohibits outsourcing facilities from registering as pharmacies, and still others require only that outsourcing facilities be registered as pharmacies if they compound patient-specific prescriptions. These differing and even contradictory requirements can be a hurdle for outsourcing facilities seeking to do business in multiple states with conflicting requirements. In the majority of states that recognize outsourcing facilities, they are overseen by the state board of pharmacy. However, in some other states, outsourcing facilities are regulated by another entity. For example, outsourcing facilities in Louisiana are overseen by the state Board of Drug and Device Distributors. Outsourcing facilities must pay to register with FDA, and the states that separately license or register these facilities also charge for licensure or registration. State fees range from about $50 to $,70 per year. Some states require outsourcing facility renewal annually, while others require renewal biennially or triennially. In-state pharmacy inspections Facility inspection is a key instrument that regulatory bodies use to assess pharmacy compliance with laws and regulations on compounding. Inspections protect the public by ensuring that appropriate quality standards are met. The frequency of inspections for traditional pharmacies located in a given state is not typically dictated by that state s laws or regulations, but is instead often based on resources. Best practice recommendations include annual inspections of facilities that perform sterile compounding. 0 Our study found that states and the District of Columbia conduct routine inspections of traditional pharmacies that perform sterile compounding for humans in their respective states at least annually. Four states conduct routine inspections of in-state facilities at least every 8 months, eight states at least every two years, one state at least every three years, and another state at least every five years. Nine states inspect with no specific stated frequency. North Carolina conducts routine inspections based on sterile compounding risk level: annually for high risk, biennially for medium risk, and at least every four years for low risk, although the state s board of pharmacy reports that the frequency of routine inspections for pharmacies engaged in low-risk sterile compounding is typically more often than every four years. Colorado conducts routine inspections at least annually but inspects pharmacies engaged in high-risk sterile compounding at least every six months. It appears that states may be inspecting traditional pharmacies less frequently now than in 05. Then, 6 states and the District of Columbia conducted routine inspections at least annually for in-state pharmacies that perform sterile compounding; now just states and the District do so. This may be due to resource constraints. Representatives from all four state boards of pharmacy interviewed for this report described the need for more resources and inspection capacity. The circumstances that state boards of pharmacy report most commonly trigger state pharmacy inspections are initial licensure, when a pharmacy remodels or moves, and when a complaint or incident occurs. Other circumstances include licensure renewal and random inspections. Missouri may inspect pharmacies if the risk level of activity changes. 3

17 Inspector education and training Sterile compounding is a complex technical practice. To effectively identify areas of concern, best practice recommendations detail inspector qualifications: State and third-party inspectors of sterile compounding pharmacies should be educated and trained to examine the type of facility they are reviewing. Some states have turned to the National Association of Boards of Pharmacy (NABP) for inspection assistance. For example, after the 0-3 fungal meningitis outbreak, New Jersey thoroughly reviewed all of its pharmacies and subsequently requested that NABP provide assistance with training and inspections. A New Jersey inspector accompanied NABP representatives on an inspection of every pharmacy in the state. Many states have used training provided by CriticalPoint LLC, a company that offers a hands-on training program tailored for state inspectors. In some states, pharmacy inspectors are not specialists in compounding or even in the practice of pharmacy. In such states, the same staff members may investigate compliance in several professions. Out-of-state pharmacies State boards of pharmacy also regulate compounders shipping drugs into their respective states, often referred to as out-of-state or nonresident pharmacies. Oversight of out-of-state pharmacies varies. Many state boards of pharmacy are concerned about nonresident pharmacies, especially those shipping in large quantities of compounded drugs, and have taken, or are taking, action to strengthen oversight of out-of-state facilities. Best practice recommendations published in 06 instruct states to hold out-of-state traditional compounding pharmacies that ship into the state to USP quality standards at a minimum and subject out-of-state pharmacies to the same frequency of inspections as in-state pharmacies, whether conducted by the state or a third party. 3 Quality standards for nonresident pharmacies Twenty-four states require out-of-state pharmacies that ship products into their states to comply with their own state s sterile compounding quality standards. In other words, if the state requires in-state pharmacies to comply with USP Chapter <797>, the state also requires out-of-state pharmacies to comply with it. Ten states and the District of Columbia require out-of-state pharmacies to comply with the quality standards of the jurisdiction where the pharmacy is located. Four states require nonresident pharmacies to comply with both their state s quality standards and the quality standards of the state where the pharmacy is located. The Idaho State Board of Pharmacy will permit an out-of-state pharmacy to ship compounded drugs to Idaho if the board determines, evidenced by an inspection report, that the other state s standards are comparable to Idaho s and acceptable to the board. 4 4

18 Inspections of nonresident pharmacies Forty-one states and the District of Columbia require out-of-state traditional pharmacies that perform sterile compounding for humans to be inspected, though the frequency of required inspections varies. Fourteen states said they do not specify the frequency with which out-of-state traditional pharmacies must be inspected. Fourteen states require inspections at least every two years, two states require inspections at least every year, two states at least every 8 months, and one state at least every five years. Arizona, North Carolina, and Washington report requiring nonresident traditional pharmacies that perform sterile compounding for humans to be inspected based on their respective home state s inspection schedule. Responsibility for conducting inspections of out-of-state traditional pharmacies varies by state. The majority of state boards of pharmacy that require nonresident pharmacies to be inspected report that they rely on inspections conducted by the regulatory or licensing agency of the jurisdiction in which the pharmacy is located. However, California reports that it conducts its own inspections of out-of-state pharmacies. Some states said they rely on third parties to conduct these inspections. For example, Texas requires out-of-state pharmacies to be inspected by either the Texas State Board of Pharmacy or one of three third-party organizations: Accreditation Commission for Health Care Inc., NABP, or Superior Laboratory Services Inc. Even without formal inspection authority, state boards may employ mechanisms to learn more about nonresident pharmacies shipping into the state. For example, the New Jersey State Board of Pharmacy does not have legal authority to inspect out-of-state pharmacies. In an effort to collect the same information about the policies and procedures of both in-state and out-of-state traditional pharmacies that perform sterile compounding, the board requires all pharmacies engaging in sterile compounding to fill out a comprehensive questionnaire before licensure. Representatives from all four state boards of pharmacy interviewed for this report identified concerns about interstate shipment of compounded drugs. Lack of harmonization of inspection forms and processes is a challenge for state boards trying to assess sterile compounding oversight in sister states. NABP is spearheading an effort to standardize pharmacy inspections across states. After seeking input from state boards of pharmacy, the organization created the multistate pharmacy inspection blueprint program. Its goal is to bring uniformity to sterile compounding pharmacy inspections while also allowing state boards of pharmacy to ensure compliance with their own state-specific requirements. 5 The blueprint program helps state regulators make decisions about licensure of out-of-state pharmacies. Pharmacies in blueprint states are inspected at least every 8 months and meet minimum standards that aim to ensure a safe supply of compounded medications. To become a blueprint state, a state board of pharmacy can have NABP compare its inspection forms to the blueprint to ensure that it covers minimum standards, or it can use NABP s universal inspection form. NABP began enlisting participation in the blueprint program in December 06. Ten states have signed on, and more than 0 others are actively considering participation. 5

19 Recommendations Across states, policy implementation and enforcement efforts are underway to better ensure a safe supply of compounded drugs. However, additional efforts could accomplish even more. In general, states should continue to examine existing systems closely and address any gaps to align with the best practices identified in concert with Pew s advisory committee of state regulators and other experts and published in Specific recommended emphasis areas arising from this research include the following: Regardless of where sterile compounding occurs, quality assurance is critical. States should require traditional compounders to comply, at minimum, with all applicable USP standards. States should ensure that any future revisions of USP standards are reflected in state requirements. States that permit traditional compounders to produce office stock should align their policies with federal law and guidance on dispensing/distributing without prescriptions. To facilitate alignment with this best practice without driving compounding activity into settings with less oversight, states should move toward meaningful regulation of sterile compounding that occurs in physicians offices. (While compounding by practitioners other than pharmacists and physicians is outside of the scope of Section 503A of the FDCA and thus not addressed in this report, consistent oversight in all settings where compounding occurs would mitigate the risk of pushing compounding activity into settings that may not meet appropriate quality standards.) States whose inspectors have not been able to inspect sterile compounding facilities annually should ensure that oversight boards effectively utilize personnel and resources. In any situation, but particularly when resources are limited, states should prioritize inspections using a risk-based approach in which oversight of higher-risk activities, such as preparing sterile drugs using nonsterile starting ingredients, are subject to more frequent inspection. Mechanisms to harmonize inspections of out-of-state pharmacies, such as the multistate pharmacy inspection blueprint program, can also help states use resources more efficiently by facilitating reliance on other states inspections. Since the last assessment, new options for inspector training have been developed. Through these or other means, best practices we published in 06 recommend that states require inspectors of sterile compounding pharmacies to be educated and trained to examine the type of facility they are reviewing. Conclusion The 06 best practices document developed in 04 by an advisory committee of state regulators and other experts, and published alongside Pew s first assessment of state policy in 06 identified the most important state practices in the regulation of compounding. Although 03 federal legislation created a new role for FDA to oversee compounding facilities that produce stock supplies of drugs without prescriptions, states remain the primary regulators of traditional pharmacy compounding. As such, states are responsible for establishing appropriate oversight systems to protect patients from the risk of contaminated or substandard compounded products. The significant progress in adoption of USP Chapter <797> quality standards and harmonizing policies on compounding without prescriptions with federal law suggest a key opportunity for jurisdictions that have not yet adopted those best practices to come into line with the majority that have. Improvements in inspection frequency for facilities that perform sterile compounding will require resources, but interim measures such as harmonizing inspection forms and processes among states may enhance efficiencies and allow states to optimize use of existing resources. 6

20 Appendix A: Methodology and characteristics of participating states Methodology The research team used publicly available sources, such as websites for state boards of pharmacy, to assess state policies regarding oversight of sterile drug compounding. The team then developed a questionnaire (see Appendix B) to standardize the format of information it collected. After pre-populating the questionnaire with the data it had collected, the team asked each state board of pharmacy to verify or correct the pre-populated answers. To determine whether a state s quality standards that did not explicitly require compliance with USP Chapter <797> were potentially equivalent to USP s requirements and should be indicated as such on the pre-populated questionnaire, a licensed pharmacist on Pew s staff compared the state requirements to USP. If the state s requirements were judged to be at least as restrictive as those in Chapter <797> even if they were different from, less specific than, or missing certain provisions from <797> that state was identified as potentially having equivalent quality standards. States were then asked to verify whether Pew s determination was accurate. Ten of the states identified as having standards potentially equivalent to USP verified that their policies were indeed equivalent to or stricter than the correlating requirements of USP; one state did not respond. In this report, each of these states is characterized as having strong standards. When reviewing the states data verification responses, the research team discovered that a question about office stock policies had been interpreted differently by similarly situated states. Specifically, several states with laws permitting compounding for office stock but which prohibit the practice in accordance with federal law responded in different ways. Some indicated that office stock was allowed, and others indicated that it was not. Consequently, to ensure that the results accurately reflected state policy, the research team added a step to its data verification process. It followed up with states to clarify whether they prohibit traditional pharmacies from office stock compounding for human use under state law or because they consider the federal law to override state law. The research team also interviewed personnel from four state boards of pharmacy to gain a qualitative understanding of state oversight of drug compounding, including any oversight gaps or other issues that may create ongoing risks to patient safety. The research team had randomly selected 0 states from which it would request interviews, and officials from the four states interviewed were those that agreed to participate. Characteristics of participating states Boards of pharmacy from 43 states and the District of Columbia responded to the research team s request to verify or correct the data collected about their oversight of sterile drug compounding. The respondents were generally representative of the main U.S. census regions: Northeast (six of nine states, or 67 percent), Midwest ( of states, or 9 percent), South (3 states and the District of Columbia, of the region comprising 6 states and the District of Columbia, or 8 percent), and West (all 3 states, or 00 percent). According to 06 census data, the states that responded represented the majority of the population in each region: Northeast (69 percent), Midwest (8 percent), South (78 percent), and West (00 percent). Four state boards of pharmacy agreed to be interviewed for this report: those in California, Iowa, New Jersey, and New York. States in three of 7

21 the four main census regions were represented in the interviews (Northeast, Midwest, and West). Three state boards of pharmacy from the South were randomly selected for interviews but either declined to participate or did not respond to a request for an interview. Results from data collection and subsequent verification by state boards of pharmacy, as well as from interviews with officials from the four states, are described and discussed in this report. Data from all states are available in Appendix C. Study limitations This study had a couple of limitations. First, although it achieved a state verification rate of more than 85 percent from the 50 states and the District of Columbia, seven states did not respond to the research team s request to verify or correct the data collected about their state s oversight of sterile drug compounding. Second, state boards of pharmacy are responsible for defining state oversight of pharmacy compounding practice, and representatives from these regulatory bodies should thus be authorities on the most current status in their jurisdictions. The authors are therefore confident that respondents participating in this study were among the most appropriate and knowledgeable sources to verify information on current state oversight practices. Nonetheless, it is possible that another authority could interpret the policies differently from the state boards of pharmacy. 8

22 Appendix B: Questionnaire Instructions: Please verify the answers to the questions below. If an answer is not accurate, please correct it and return this form with the correct answers. U.S. Pharmacopeia (USP) Chapter <797> Does your state require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP Chapter <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP Chapter <797>)? Full compliance with USP Chapter <797> Equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP Chapter <797>) No If yes, what is the legislation or regulation that mandates full compliance with USP Chapter <797> or equivalent quality standards? Name of legislation or regulation If yes, will legislative or regulatory change be needed to require compliance with the updated version of USP Chapter <797> when it is finished? (Please note that if the answer to this question was unclear or ambiguous to us based on reading the legislation or regulation that mandates full compliance with USP Chapter <797> or equivalent quality standards in your state, we defaulted to no.) No If no, does your state require 503A pharmacies that compound sterile drugs for humans to comply with quality standards? No If yes, what is the legislation or regulation that mandates these standards? Name of legislation or regulation 9

23 Office stock Does your state allow 503A pharmacies (pharmacies that are not registered with the U.S. Food and Drug Administration (FDA) as outsourcing facilities) to compound sterile drugs for humans in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry)? No If no, what is the legislation, regulation, or board of pharmacy or state document that prohibits 503A pharmacies from compounding sterile drugs for humans in the absence of patient-specific prescriptions? Name of legislation, regulation, or board of pharmacy or state document If no, does your state allow 503A pharmacies to compound nonsterile drugs for humans in the absence of patient-specific prescriptions (outside of anticipatory compounding)? No If yes, does your state apply specific limits on 503A pharmacies compounding sterile drugs for humans in the absence of patient-specific prescriptions? No If yes, what are the limits? Check all that apply. Limited quantities, specify Limited distribution, specify For in-office administration only, specify With special agreement approved by the board of pharmacy, specify Other, specify If yes, what is the legislation or regulation that specifies these limits? Name of legislation or regulation 0

24 Outsourcing facilities Does your state license or register facilities that register with the FDA under the new federal outsourcing facility category of drug compounders? No If yes, how does your state license or register these facilities? Check all that apply. License or register as pharmacy (if facility compounds patient-specific prescriptions) License or register as outsourcing facility License or register as manufacturer License or register as wholesale distributor Other, specify If yes, what is the legislation, regulation, or board of pharmacy or state document that requires such licensure or registration? Name of legislation, regulation, or board of pharmacy or state document If yes, is there a fee for licensure or registration? No If yes, what is the fee for initial licensure or registration? $ If yes, what is the fee for licensure or registration renewal? $ In-state inspections How frequently does your state conduct routine inspections for in-state 503A pharmacies that perform sterile compounding for humans? (Please note that we answered this question with the answer reported in the National Assessment of State Oversight of Sterile Drug Compounding.) At least every year At least every 8 months At least every two years No specific frequency Other, specify

25 What specific circumstances trigger your state to conduct inspections for in-state 503A pharmacies that perform sterile compounding for humans? Check all that apply. (Please note that we answered this question with the answer reported in the National Assessment of State Oversight of Sterile Drug Compounding.) Licensure renewal Other, specify Out-of-state inspections For out-of-state 503A pharmacies that perform sterile compounding for humans, which quality standards does your state require? Your state requires an out-of-state 503A pharmacy to comply with your state s sterile compounding quality standards Your state requires an out-of-state 503A pharmacy to comply with the sterile compounding quality standards of the state where the pharmacy is located Other, specify Does your state require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected? No If yes, how frequently? At least every year At least every 8 months At least every two years No specific frequency Other, specify If yes, who performs the inspections? Check all that apply. Your state The regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party, specify Other, specify

26 Pending policy changes Does your state have pending legislation or regulations related to oversight of sterile compounding for humans? No If yes, what would the pending legislation or regulation do if passed? Check all that apply. Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP Chapter <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP Chapter <797>) Prohibit 503A pharmacies (pharmacies that are not registered with FDA as outsourcing facilities) from compounding sterile drugs for humans in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Prohibit 503A pharmacies from compounding nonsterile drugs for humans in the absence of patient-specific prescriptions (outside of anticipatory compounding) License or register facilities that register with the FDA under the new federal outsourcing facility category of drug compounders If so, how would your state license or register these facilities? Check all that apply. License or register as pharmacy (if facility compounds patient-specific prescriptions) License or register as outsourcing facility License or register as manufacturer License or register as wholesale distributor Other, specify Require out-of-state 503A pharmacies that perform sterile compounding for humans to comply with your state s sterile compounding quality standards Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected If so, how frequently? At least every year At least every 8 months At least every two years No specific frequency Other, specify If so, who would perform the inspections? Check all that apply. Your state The regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party, specify Other, specify Other, specify 3

27 Appendix C: Complete tables of state oversight of sterile compounding Forty-three state boards of pharmacy and the District of Columbia Board of Pharmacy responded to the research team s request to verify that the data collected about their respective state s oversight of sterile drug compounding were accurate, and/or to correct any inaccurate information. Seven states (Alabama, Connecticut, Delaware, Florida, Illinois, Maine, and Pennsylvania) did not verify that the data collected were accurate. Table C. Quality Standards for 503A Pharmacies That Compound Sterile Drugs for Humans Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Alabama No Requires compliance with other quality standards (Code of Alabama, Title 34, Chapter 3, Practice of Pharmacy Act 05, Pharmacists and Pharmacies, Article 7. Compounding of Drugs) Pending legislation or regulation and what it would do if passed Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Alaska No Arizona Arkansas California Full compliance with USP <797> (Arizona Revised Statutes, Pharmacy Act: Title 3 Chapter 8, Article Board of Pharmacy: Definitions) Equivalent quality standards (Arkansas State Board of Pharmacy, Regulation 7: Drug Products/ Prescriptions, 07-0 Compounding) Equivalent quality standards (California Code of Regulations, Division 7, Title 6, Article 7. Sterile Compounding) Equivalent quality standards ( Alaska Administrative Code, Chapter 5. Board of Pharmacy, Article 4. Guidelines for Pharmacies and Pharmacists, 440. Guidelines Relating to Compounding Practices) No Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Colorado (Department of Regulatory Agencies, State Board of Pharmacy Rules, Rule.00.00, Compounding, Code of Colorado Regulations 79-, Compounding) No Continued on next page 4 5

28 Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Requires compliance with other quality standards Pending legislation or regulation and what it would do if passed Full compliance with USP <797> Connecticut (Connecticut General Statutes Annotated, Title 0. Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards, Chapter 400J. Pharmacy, Part III. Practice of Pharmacy, 0-633b. Sterile compounding pharmacies. Requirements. Regulations) Full compliance with USP <797> No Delaware (Delaware Regulations, Administrative Code, Title 4, 500 Board of Pharmacy, 0.0 Pharmaceutical Compounding, 0. Non-Sterile and Sterile Preparations) District of Columbia No Florida Georgia Full compliance with USP <797> (Rule Chapter: 64B6-7: Pharmacy Practice, 64B The Standards of Practice for Compounding Sterile Products) Full compliance with USP <797> (Rules and Regulations of the State of Georgia, Chapter (5) and (8) Pharmaceutical Compounding) Full compliance with USP <797> No (Title District of Columbia Municipal Regulation, Chapter 9. Pharmacies) No Hawaii (Hawaii Administrative Rules, Title 6 Department of Commerce and Consumer Affairs, Chapter 95 Pharmacists and Pharmacies, Subchapter 3 Disciplinary Sanctions, Application Denial, Hearings, Administrative Practice and Procedure, Grounds for revocation, suspension, refusal to renew or restore, denial, or conditioning of license or permit) No Idaho No Equivalent quality standards (Idaho Administrative Code, Idaho Administrative Procedures Act, 7 Board of Pharmacy, Rules of the Idaho State Board of Pharmacy, Subchapter C General Practice Standards, 39. Compounding Drug Products) Illinois Indiana (Administrative Code, Title 68: Professions and Occupations, Chapter VII: Department of Financial and Professional Regulation, Subchapter b: Professions and Occupations, Part 330 Pharmacy Practice Act, Section Compounded Sterile Preparation Standards) Full compliance with USP <797> (Title 856 Indiana Board of Pharmacy, Article. Pharmacies and Pharmacists, Rule 30. Sterile Pharmaceuticals; Preparation and Dispensing) Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Continued on next page 6 7

29 Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Requires compliance with other quality standards Pending legislation or regulation and what it would do if passed Full compliance with USP <797> Iowa (Iowa Administrative Code, Pharmacy Board [657], Chapter 0 Compounding Practices, (4,6,55A) Sterile compounding) No Kansas No No Kentucky Full compliance with USP <797> (Kentucky Revised Statutes Chapter 7.05 Definitions for KRS to 7.5; 0 KAR :076) Full compliance with USP <797> Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Louisiana Maine Maryland Massachusetts Michigan Minnesota (Louisiana Administrative Code, Title 46 Professional and Occupational Standards, Part LIII: Pharmacists, Chapter 5. Prescriptions, Drugs, and Devices, Subchapter C. Compounding of Drugs, 535. General Standards) Full compliance with USP <797> (State of Maine Rules for the Department of Professional and Financial Regulation, Chapter 0-39: Maine Board of Pharmacy, Chapter 37: Licensure of Sterile Compounding Pharmacies) Full compliance with USP <797> (Code of Maryland Regulations, Title 0 Department of Health and Mental Hygiene, Subtitle 34 Board of Pharmacy, Chapter 9 Sterile Pharmaceutical Compounding) Full compliance with USP <797> (M.G.L. c, 39G and 47 CMR 9.0(3)) Full compliance with USP <797> (Public Health Code, Act 368 of 978, Part 77 Pharmacy Practice and Drug Control, Section a Compounding services for sterile pharmaceuticals; accreditation; notification of complaint; maintenance and retention of records; resale of excess compounded pharmaceuticals prohibited; distribution of samples or complimentary starter doses; advertisement or promotion of compounding services; compounding pharmaceutical that is unavailable in marketplace; compounding and manufacturing at same location; rules) Full compliance with USP <797> (Minnesota Administrative Rules, Compounding Standards, Subp.. Standards for sterile compounding) No No The Board of Registration in Pharmacy has pending regulations in the form of 47 CMR 7.00: Sterile Compounding. This pending regulation will clarify USP <797> standards, provide greater instruction for licensees, and in some cases go above and beyond USP <797>. No No Continued on next page 8 9

30 Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Requires compliance with other quality standards Pending legislation or regulation and what it would do if passed Full compliance with USP <797> Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey (Title 30: Professions and Occupations, Part 300: Mississippi Pharmacy Practice Regulations, Article XXVIII Regulations for Preparation of Sterile Pharmaceuticals) Equivalent quality standards (Rules of Department of Insurance, Financial Institutions and Professional Registration, Division 0 State Board of Pharmacy, Chapter General Rules, 0 Code of State Regulations Sterile Compounding) Full compliance with USP <797> (Rule Chapter: 4.74: Board of Pharmacy, Subchapter 8 Pharmacies, Sterile Products) Full compliance with USP <797> (State of Nebraska, Statutes Relating to Pharmacy Practice Act, Pharmacy; scope of practice; prohibited acts; violation; penalty, Authority to compound; standards; labeling; prohibited acts) Equivalent quality standards (Nevada Administrative Code, Chapter 639 Pharmacists and Pharmacy, Compounding and Dispensing Drug Products) Full compliance with USP <797> (Administrative Rules, Chapter Ph 00 Organizational Rules, Part Ph 404 Standards for Compounding and Dispensing Sterile and Non-Sterile Pharmaceuticals) Equivalent quality standards (New Jersey Administrative Code, Title 3 Law and Public Safety, Chapter 39 State Board of Pharmacy, Subchapter. Compounding Sterile Preparations in Retail and Institutional Pharmacies; Regulations also address Hazardous Compounding in New Jersey Administrative Code, Title 3 Law and Public Safety, Chapter 39 State Board of Pharmacy, Subchapter B Compounding of antineoplastic agents and other hazardous substances) Full compliance with USP <797> No No New Mexico (New Mexico Statutes Annotated, Chapter 6 Drugs and Cosmetics, Article General Provisions, Section 6--. Definitions) New York No No (Title 8 NYCRR in 9. and 9. A4 and Education Law, Article 37) Continued on next page 30 3

31 Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Requires compliance with other quality standards Pending legislation or regulation and what it would do if passed Full compliance with USP <797> North Carolina North Dakota Ohio (North Carolina Administrative Code, Board of Pharmacy Pharmacy Rules, Section.800 Compounding, NCAC Compounding) Full compliance with USP <797> (Administrative Code (Rules/Regulations), Chapter Pharmacy Permits, Section Pharmaceutical compounding standards) Full compliance with USP <797> (Ohio Administrative Code, 479 State Board of Pharmacy, Chapter Drug Compounding, Drugs compounded in a pharmacy) Full compliance with USP <797> No Oklahoma (Oklahoma Administrative Code, Title 535. Oklahoma State Board of Pharmacy, Chapter 5. Pharmacies, Subchapter 0. Good Compounding Practices, Part 3. Good Compounding Practices for Sterile Products) Oregon No Pennsylvania No Equivalent quality standards (Oregon Administrative Rules, Board of Pharmacy, Division 45 Sterile and Non-Sterile Compounding) (The Pennsylvania Code, Chapter 7. State Board of Pharmacy) Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards Rhode Island South Carolina South Dakota Tennessee (Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors [R5-9.-PHAR], Part IV Specialized Pharmacy Practice, Section 9.0 Compounding of Pharmaceuticals) Full compliance with USP <797> (South Carolina Board of Pharmacy Policies & Procedures, Sterile Compounding Policy and Procedure #37) Equivalent quality standards (Administrative Rules of South Dakota, Article 0:5 Pharmacists, Chapter 0:5:3, Sterile Compounding Practices) Full compliance with USP <797> (Rules of the Tennessee Board of Pharmacy, Chapter Sterile Product Preparation in Pharmacy Practice) No Require 503A pharmacies that compound sterile drugs for humans to be in full compliance with USP <797> or equivalent quality standards No Continued on next page 3 33

32 Requires full compliance with USP <797> or equivalent quality standards (i.e., state requirements on sterile compounding practice are equivalent to or stricter than the correlating requirements of USP <797>) Legislative or regulatory change will be needed to require compliance with the updated version of USP <797> when it is finished Requires compliance with other quality standards Pending legislation or regulation and what it would do if passed Equivalent quality standards Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming (Texas Administrative Code, Title Examining Boards, Part 5 Texas State Board of Pharmacy, Chapter 9 Pharmacies, Subchapter G Services Provided by Pharmacies, Rule 9.33 Pharmacies Compounding Sterile Preparations) Full compliance with USP <797> (R56. Commerce, Occupational and Professional Licensing, R56-7b. Pharmacy Practice Act Rule, R56-7b-64a. Operating Standards General Operating Standards, Class A and B Pharmacy) Full compliance with USP <797> (Administrative Rules of the Board of Pharmacy, Part 3 Sterile Pharmaceuticals, 3. USP 797 Compliance for Compounded Sterile Products) Full compliance with USP <797> (Commonwealth of Virginia, Chapter 0 Regulations Governing the Practice of Pharmacy, Part VII. Prescription Order And Dispensing Standards, 8VAC Compounding and Chapter 34 of Title 54. of the Code of Virginia, The Drug Control Act, Compounding; pharmacists authority to compound under certain conditions; labeling and record maintenance requirements) Full compliance with USP <797> (Revised Code of Washington, Chapter 8.64 Pharmacists, Section Responsibility for drug purity Compounding Adulteration Penalty) Full compliance with USP <797> (Title 5 Legislative Rule West Virginia Board of Pharmacy, Series Licensure and Practice of Pharmacy, Sterile Pharmaceutical Compounding) Equivalent quality standards (Wisconsin Administrative Code, Pharmacy Examining Board, Chapter Phar 5 Sterile Pharmaceuticals) Full compliance with USP <797> (State of Wyoming Pharmacy Act Rules and Regulations, Chapter 7 Sterile Compounding) No No No No 34 35

33 Table C. Policies on 503A Pharmacies Compounding Drugs for Humans in the Absence of Patient-Specific Prescriptions Alabama Alaska Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) No, restricts through state guidance (Alabama Board of Pharmacy Sterile Compounding Frequently Asked Questions) No, restricts through state law or regulation (AS Pharmacists and Pharmacies Statutes) Arizona Arkansas No, advises pharmacies to follow federal law through informal state board of pharmacy communication (Board advises all 503A facilities that to do non-patient-specific human compounding without a 503B permit would be a violation of FDA rules so they cannot do so.) California Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions No No Limited quantities: Not to exceed five percent of the pharmacy s gross sales (Article 3. Regulation of Full Service Wholesale Permittees, Definitions) No Limited quantities: A reasonable quantity, which means that amount of compounded drug preparation that is ordered by the prescriber or the prescriber s agent using a purchase order or other documentation received by the pharmacy prior to furnishing that lists the number of patients seen or to be seen in the prescriber s office for whom the drug is needed or anticipated, and the quantity for each patient that is sufficient for office administration; and is delivered to the prescriber s office and signed for by the prescriber or the prescriber s agent; and is sufficient for administration or application to patients solely in the prescriber s office; and that the pharmacist has a credible basis for concluding it is a reasonable quantity for office use considering the intended use of the compounded medication and the nature of the prescriber s practice; and with regard to any individual prescriber to whom the pharmacy furnishes, and with regard to all prescribers to whom the pharmacy furnishes, is an amount which the pharmacy is capable of compounding in compliance with 4 pharmaceutical standards for integrity, potency, quality and strength of the compounded drug preparation; and does not exceed an amount the pharmacy can reasonably and safely compound For in-office administration only: Administration or application to patients solely in the prescriber s office Pending legislation or regulation and what it would do if passed Colorado (California Code of Regulations, Division 7, Title 6, Article 4.5 Compounding, Section Compounding Limitations and Requirements; Self-Assessment) Limited quantities: For in-state pharmacies only 0 percent of the total number of dosage units dispensed and distributed in a calendar year (Section (6), C.R.S. and Board Rule.00.00) Continued on next page 36 37

34 Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions Pending legislation or regulation and what it would do if passed No, restricts through state law or regulation Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa (Connecticut General Statutes Annotated, Title 0. Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards, Chapter 400J. Pharmacy, Part III. Practice of Pharmacy, 0-633b. Sterile compounding pharmacies. Requirements. Regulations) No, restricts through state law or regulation (Delaware Regulations, Administrative Code, Title 4, 500 Board of Pharmacy, 5.0 Dispensing) No, restricts through state law or regulation (Title District of Columbia Municipal Regulation, Chapter 9. Pharmacies, Sec 999 Definitions) No, restricts through state law or regulation (Rule Chapter: 64B6-7: Pharmacy Practice, 64B Definition of Compounding) No, restricts through state guidance (State of Georgia Drugs and Narcotics Agency 06 letter) No, restricts through state law or regulation (Board of Pharmacy interpretation of various pharmacy laws/rules that a valid prescription that is patient-specific is required for any pharmacies to dispense a prescription drug) No, restricts through state law or regulation (Idaho Administrative Code, Idaho Administrative Procedures Act, 7 Board of Pharmacy, Rules of the Idaho State Board of Pharmacy, Subchapter E Drug Outlet Practice Standards, 65. Drug Distribution) No, restricts through state law or regulation (Title 68: Professions and Occupations Chapter VII: Department of Financial and Professional Regulation Subchapter B: Professions and Occupations Part 330 Pharmacy Practice Act Section Pharmaceutical Compounding Standards) No, restricts through state law or regulation (Title 856 Indiana Board of Pharmacy, Article. Pharmacies and Pharmacists, Rule 30. Sterile Pharmaceuticals; Preparation and Dispensing) No, restricts through state law or regulation (Iowa Administrative Code, Pharmacy Board [657], Chapter 0 Compounding Practices, 657 (4,6,55A) Compounding for office use) No No No No No No Continued on next page 38 39

35 Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Kansas Kentucky No, restricts through state guidance (Kentucky Board of Pharmacy Compounding FAQs) No, restricts through state law or regulation Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions Limited quantities: Minimal quantities of drugs (Pharmacy Practice Act Statutes, Chapter 65. Public Health, Article 6. Regulation of Pharmacists, Definitions) No Pending legislation or regulation and what it would do if passed Louisiana Maine Maryland Massachusetts (Louisiana Administrative Code, Title 46 Professional and Occupational Standards, Part LIII: Pharmacists, Chapter 5. Prescriptions, Drugs, and Devices, Subchapter C. Compounding of Drugs, 535. General Standards) No, restricts through state law or regulation (3 MRS 370-A(4)) No, restricts through state law or regulation (Code of Maryland Regulations, Title 0 Department of Health and Mental Hygiene, Subtitle 34 Board of Pharmacy, Chapter 9 Sterile Pharmaceutical Compounding,.9 Office Use) No, restricts through state law or regulation (M.G.L. c, 39F; M.G.L. c. 94C 7) No No No Limited quantities: Limited quantities For in-office administration only: For a prescriber or health facility or agency licensed under article 7 to administer to the prescriber s, facility s, or agency s patients Michigan No, restricts through state law or regulation With special agreement approved by the board of pharmacy: Upon application by a pharmacist or compounding pharmacy, the department may authorize the pharmacist or compounding pharmacy (Public Health Code, Act 368 of 978, Part 77 Pharmacy Practice and Drug Control, Section b Compounding nonsterile or sterile pharmaceuticals for prescriber or health facility or agency to administer to patients without prescription; authorization; report of adverse event; list of authorized pharmacies and pharmacists; selling or redispensing to prescriber or health facility or agency) Minnesota Mississippi (Minnesota Statute 5.0, subd. 35, definition of Compounding, and Minnesota Administrative rules, Compounding and Dispensing) No, restricts through state law or regulation (Title 30: Professions and Occupations, Part 300: Mississippi Pharmacy Practice Regulations, Article XXXI Compounding Guidelines) No No Continued on next page 40 4

36 Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions Pending legislation or regulation and what it would do if passed No, restricts through state law or regulation Missouri Montana Nebraska (Rules of Department of Insurance, Financial Institutions and Professional Registration, Division 0 State Board of Pharmacy, Chapter General Rules, 0 Code of State Regulations Compounding Standards of Practice) No, restricts through state law or regulation (Statute: (9), MCA, (39), MCA; Rule: ARM ) No, restricts through state guidance (Pharmacies should be FDA-registered outsourcing facilities to comply with federal regulations per Board meeting minutes) Nevada No No No For in-office administration only: A pharmacy may compound for administration by a practitioner (office use) (Nevada Administrative Code, Chapter 639 Pharmacists and Pharmacy, Compounding and Dispensing Drug Products) Limited quantities: A batch with 50 or less dosage units New Hampshire No, restricts through state law or regulation For in-office administration only: Compounding includes preparation of drugs and devices on the order of a practitioner, which may be sold to the practitioner for use in his or her office to administer to a specific patient, but not for resale (Administrative Rules, Chapter Ph 00 Organizational Rules, Part Ph 404 Standards for Compounding and Dispensing Sterile and Non-Sterile Pharmaceuticals) New Jersey New Mexico New York North Carolina North Dakota (New Jersey Administrative Code, Title 3 Law and Public Safety, Chapter 39 State Board of Pharmacy, Subchapter. Compounding Sterile Preparations in Retail and Institutional Pharmacies 3:39-.8 Compounded Sterile Preparations for Prescriber Practice Use) No, restricts through state law or regulation ( NMAC) No, restricts through state law or regulation (Education Law, Article 37, Pharmacy) No, restricts through state law or regulation (North Carolina Administrative Code, Board of Pharmacy Pharmacy Rules, Section.800 Compounding, NCAC Compounding; federal Drug Quality and Security Act) No, advises pharmacies to follow federal law through informal state board of pharmacy communication (Federal law pre-empts our state law and communicating through multiple channels) No No No No No Continued on next page 4 43

37 Ohio Oklahoma Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) No, restricts through state law or regulation (Rule ) No, restricts through state law or regulation (Oklahoma Administrative Code, Title 535. Oklahoma State Board of Pharmacy, Chapter 5. Pharmacies, Subchapter 0. Good Compounding Practices, Part 3. Good Compounding Practices for Sterile Products) Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions No No Limited distribution: For a practitioner or dispenser located in Oregon Pending legislation or regulation and what it would do if passed Oregon With special agreement approved by the board of pharmacy: Compounding by a pharmacy located in Oregon for a practitioner or dispenser located in Oregon that is covered by a Shared Pharmacy Services agreement as defined in OAR Other: Compounding by a pharmacy located in Oregon (POSSIBLY) Prohibit 503A pharmacies from compounding sterile drugs for humans in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) (Oregon Administrative Rules, Board of Pharmacy, Division 45 Sterile and Non-Sterile Compounding) Pennsylvania No, restricts through state law or regulation (The Pennsylvania Code, Chapter 7. State Board of Pharmacy, 7.8. Standards of practice) No Allow 503A pharmacies to compound sterile and nonsterile drugs for humans in the absence of patient-specific prescriptions only for distribution to a medical practitioner to administer to an individual patient if the medical practitioner has an administrative system whereby the product can be tracked through the medical practitioner to the individual patient No, restricts through state law or regulation Rhode Island (Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors [R5-9.-PHAR], Part IV Specialized Pharmacy Practice, Section 9.0 Compounding of Pharmaceuticals) South Carolina No For in-office administration only: The minimum expected compliance for a pharmacist selling compounded products to a physician or licensed practitioner is that the pharmacist have a contract with the physician or licensed practitioner specifying that the compounded medications are for office administration only, and that lot numbers and expiration dates shall be maintained and readily retrievable on patient s records/charts (South Carolina Board of Pharmacy Policies & Procedures, Compounding Pharmacies Policy and Procedure #3) South Dakota No, restricts through state guidance (No state document, refer to federal Drug Supply Chain Security Act per Board newsletter) No Prohibit 503A pharmacies from compounding sterile and nonsterile drugs for humans in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Continued on next page 44 45

38 Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) Tennessee No, advises pharmacies to follow federal law through informal state board of pharmacy communication Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions For in-office administration only: For use in a licensed prescribing practitioner s office for administration to the prescribing practitioner s patient or patients when the product is not commercially available upon receipt of an order from the prescriber; for use in a health care facility for administration to a patient or patients receiving treatment or services provided by that facility when the product is not commercially available upon receipt of an order from an authorized licensed medical practitioner of the facility; for use by emergency medical services for administration to a patient or patients receiving services from them under authorized medical control when the product is not commercially available upon receipt of an order from a licensed prescriber authorized to provide medical control (Tennessee Code Annotated, Title 63 Professions Of The Healing Arts, Chapter 0 Pharmacy, Part Pharmacy Practice, Definitions) Pending legislation or regulation and what it would do if passed Texas (During inspections, if an inspector notices compounding only for outsourcing facilities and not pursuant to prescription or if the pharmacy is compounding inordinate quantities that exceed the amount needed for anticipatory prescriptions, Board office will advise the pharmacy to become licensed as an outsourcer by FDA, licensed with the Department of State Health Services [DSHS], and notify DSHS.) No, restricts through state law or regulation No Utah Vermont (R56. Commerce, Occupational and Professional Licensing, R56-7b. Pharmacy Practice Act Rule, R56-7b-64. Operating Standards. Repackaged or Compounded Prescription Drugs Sale to a Practitioner for Office Use) No, restricts through state law or regulation (Administrative Rules of the Board of Pharmacy, Part 0 Pharmacy Practice, 0.3 Drugs Compounded in a Pharmacy) Virginia No No For in-office administration only: A pharmacist may provide a reasonable amount of compounded products to practitioners of medicine, osteopathy, podiatry, or dentistry to administer to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law or regulations. A pharmacist may also provide compounded products to practitioners of veterinary medicine for office-based administration to their patients. Washington West Virginia No, restricts through state law or regulation (Washington Administrative Code, Title 46, Chapter ) No, restricts through state law or regulation (West Virginia Code, Chapter 30. Professions and Occupations, Article 5. Pharmacists, Pharmacy Technicians, Pharmacy Interns and Pharmacies, Definitions) ( (C) of The Drug Control Act) No No Continued on next page 46 47

39 Wisconsin Wyoming Allow compounding sterile drugs in the absence of patient-specific prescriptions (outside of the limited quantities of anticipatory compounding permitted under FDA s prescription requirement guidance for industry) No, restricts through state law or regulation (Wisconsin Administrative Code, Pharmacy Examining Board, Chapter Phar 7 Pharmacy Practice) No, advises pharmacies to follow federal law through informal state board of pharmacy communication (The more strict federal law must be followed.) No Allow compounding nonsterile drugs in the absence of patient-specific prescriptions (outside of anticipatory compounding) Limits on compounding sterile drugs in the absence of patientspecific prescriptions No Pending legislation or regulation and what it would do if passed Allow 503A pharmacies to compound sterile and nonsterile drugs for humans in the absence of patient-specific prescriptions for in-office administration only 48 49

40 Table C.3 State Licensure/Registration of Outsourcing Facilities Alabama Alaska Arizona Arkansas California Colorado License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders (Alabama Board of Pharmacy 06 licenses for pharmacies and facilities renewal letter) (Unspecified) (Application for Manufacturer Permit) (Pharmacy Practice Act, Fees) (Business & Professions Code, Chapter 9, Division, Article 7.7. Outsourcing Facilities, 49. Outsourcing Facility License Required) (Section , C.R.S.) Type of licensure or registration As outsourcing facility As pharmacy (if facility compounds patient-specific prescriptions) License or registration fee Initial fee Renewal fee Unspecified Unspecified Unspecified Unspecified As manufacturer $,000 $,000 biennially As outsourcing facility As outsourcing facility Other: In-state as manufacturers, out-of-state as out-of-state wholesalers $300 $50 annually $,70 for instate; $,380 for nonresident Varies from year to year as set by the Division of Professions and Occupations $,35 annually for in-state; $,70 annually for nonresident Varies from year to year as set by the Division of Professions and Occupations Pending legislation or regulation and what it would do if passed Connecticut No Delaware (Delaware Regulations, Administrative Code, Title 4, 500 Board of Pharmacy, 5.0 Dispensing) As outsourcing facility Other: Must hold current Delaware in-state pharmacy, nonresident pharmacy, or distributor license or apply for one of these licenses concurrently with the application for an Outsourcing Facility permit $45 for outsourcing facility retail (in-state) pharmacy; $45 for outsourcing facility nonresident pharmacy; $365 for outsourcing facility wholesale (distributor) Unspecified Continued on next page 50

41 District of Columbia Florida Georgia License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee No (The 06 Florida Statutes, Title XXXII Regulation of Professions and Occupations, Chapter 465 Pharmacy, Nonresident sterile compounding permit; Rule Chapter: 64B6-7: Pharmacy Practice, 64B Definition of Compounding) (State of Georgia Drugs and Narcotics Agency 06 letter) Other: Nonresident as outsourcing facilities. (Outsourcing facilities located in the state must register with FDA.) In order to ship, mail, deliver, or dispense, in any manner, a compounded sterile product into this state, an outsourcing facility must also hold a nonresident sterile compounding permit. As pharmacy (if facility compounds patient-specific prescriptions) As manufacturer Other: Must hold a Georgia drug manufacturing permit $55 for nonresident $500 for resident pharmacies; $,000 for nonresident pharmacies; $,000 for all manufacturers Hawaii No Unspecified $400 for resident pharmacies; $750 for nonresidents; $750 for all manufacturers biennially Pending legislation or regulation and what it would do if passed License or register facilities that register with the FDA under the federal outsourcing facility category of drug compounders as outsourcing facilities Continued on next page 5

42 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed Idaho (Idaho Administrative Code, Idaho Administrative Procedures Act, 7 Board of Pharmacy, Rules of the Idaho State Board of Pharmacy, Subchapter B Professional and Drug Outlet Licensure, 074. Outsourcing Facility Registration) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $50 for resident; $500 for nonresident $50 annually Illinois No Indiana No Iowa (Iowa Code 07, Chapter 55A Pharmacy, 55A.3C Outsourcing facility license renewal, cancellation, denial, discipline) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $35 $35 annually Kansas (Pharmacy Practice Act Statutes, Chapter 65. Public Health, Article 6. Regulation of Pharmacists, Registration or permit required; pharmacies, manufacturers, wholesalers, auctions, sales, distribution or dispensing of samples, retailers, institutional drug rooms, pharmacy students, veterinary medical teaching hospital pharmacies; certain acts declared unlawful) As pharmacy (if facility compounds patient-specific prescriptions) As manufacturer As wholesale distributor Not more than $500 Not more than $400 annually License or register facilities that register with the FDA under the federal outsourcing facility category of drug compounders as outsourcing facilities Kentucky (Kentucky Revised Statutes Chapters Permit for operation of in-state outsourcing facility doing business in Kentucky Requirements Administrative regulations and Permit for operation of out-of-state outsourcing facility doing business in Kentucky Requirements Administrative regulations) As outsourcing facility Not to exceed $500 for in-state; for out-of-state, not to exceed $50 or the current instate permit Not to exceed $500 annually for in-state; for out-of-state, not to exceed $50 annually or the current in-state permit Continued on next page 5

43 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed Louisiana (responsible agency: LA Board of Drug & Device Distributors) (Distribution is licensed by Board of Drug & Device Distributors (LBDDD), as authorized by La. R.S. 37:346 et seq. Dispensing is licensed by Board of Pharmacy (LBP), as authorized by La. R.S. 37:6 et seq.) As pharmacy (if facility compounds patient-specific prescriptions) this credential from the La. Board of Pharmacy Other: Standard distributor LBDDD: $400 LBP: $50 LBDDD: $300 LBP: $5 annually Maine No Maryland No Massachusetts (47 CMR.00: Registration of Outsourcing Facilities and M.G.L. c, 36E) As outsourcing facility $750 $750 biennially Michigan (Public Health Code, Act 368 of 978, Part 77 Pharmacy Practice and Drug Control, Section Pharmacy, manufacturer, or wholesale distributor; license required; compounding services; renewal; designation of pharmacist in charge; joint responsibility; exemption; report of change in ownership, management, location, or PIC or facility manager; duties of pharmacist in charge; submission of fingerprints; criminal history check; exception; investigation or inspection of out-of-state applicant or compounding pharmacy; reimbursement for expenses) Other: Must be licensed as a pharmacy (even if it does not compound patient-specific prescriptions) Pharmacy / Controlled Substance- Facility $8.80 Pharmacy $.0 biennially; Controlled Substance- Facility $5.50 biennially Continued on next page 53

44 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed As pharmacy (if facility compounds patient-specific prescriptions) Minnesota (Minnesota Board of Pharmacy website, license and registration 503B outsourcing facility page) As manufacturer Other: 503B outsourcing facilities must be licensed as both a drug manufacturer and a drug wholesaler $35, see website Unspecified, see website Mississippi (Title 30: Professions and Occupations, Part 300: Mississippi Pharmacy Practice Regulations, Article VI Practice of Pharmacy Permits) Other: Sterile product outsourcing permit $300 $300 biennially Missouri ( , RSMo to , RSMo) As wholesale distributor $300 $300 biennially (However, fee has been reduced by the Board for the last six years to $50) Montana (New 07 legislation, SB 68, defines outsourcing facility which will allow the Board to make rule changes to add an endorsement for outsourcing facility or sterile compounder to existing facility license types) As pharmacy (if facility compounds patient-specific prescriptions) As wholesale distributor Pharmacy (instate) $40; out-of-state mailorder pharmacy $40; wholesale drug distributor (in-state and outof-state) $40 Pharmacy (instate) $50; out-of-state mailorder pharmacy $40; wholesale drug distributor (in-state and outof-state) $40 annually Nebraska No Nevada (Nevada Administrative Code, Chapter 639 Pharmacists and Pharmacy, Outsourcing Facilities) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $500 $500 biennially Continued on next page 54

45 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed New Hampshire (Title XXX Occupations and Professions, Chapter 38 Pharmacists and Pharmacies, Section 38:5-c Licensing of Outsourcing Facilities Identified as Section 503B Facilities by the United States Food and Drug Administration) Other: Permit as bulk sterile & nonsterile compounders $50 $50 annually New Jersey No New Mexico (New Mexico Administrative Code, Title 6 Occupational and Professional Licensing, Chapter 9 Pharmacists, Part 37 Minimum Standards for Outsourcing Facilities) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $,000 $,000 biennially New York (Education Law, Article 37, Pharmacy, Registering and operating establishments and 683. Special provisions relating to outsourcing facilities) As outsourcing facility $85 $50 triennially North Carolina North Dakota Ohio (North Carolina General Statutes, Chapter 06 Agriculture, Article. Food, Drugs and Cosmetics, Registration of producers of prescription drugs and devices) (Administrative Code (Rules/ Regulations), Chapter , Wholesale Drug Pedigree, Section Compounding provided by an outsourcing facility) (Section of the Revised Code) As manufacturer $,000 $,000 annually Other: License under Wholesale Drug Pedigree chapter with an outsourcing facility classification As outsourcing facility $00 $00 annually $,900 for noncontrolled and $,000 for controlled $,900 for noncontrolled and $,000 for controlled biennially Continued on next page 55

46 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed Oklahoma (Oklahoma Administrative Code, Title 535. Oklahoma State Board of Pharmacy, Chapter 0. Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, and Medical Gas Suppliers and Distributors, Subchapter 6. Outsourcing Facilities) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $00 $00 annually Oregon (Oregon Administrative Rules, Board of Pharmacy, Division 60 Pharmaceutical Manufacturers) As manufacturer $400 $400 annually Pennsylvania No Rhode Island No South Carolina (Outsourcing Facility Permit Application; Non-Resident Outsourcing Facility Permit Application) Other: As pharmacy and outsourcing facility or as a pharmacy and wholesale distributor $00 for instate; $500 for nonresident $00 annually for in-state; $500 annually for nonresident South Dakota (South Dakota Codified Law, Chapter 36-A Wholesale and Other Drug Distributors, 36-A-4.. License required for wholesale distributors, outsourcing facilities etc.) As 503B outsourcing facility Other: Inspection requirements?. Must be inspected by the FDA prior to licensure in SD. $00 $00 annually License or register facilities that register with the FDA under the federal outsourcing facility category of drug compounders as outsourcing facilities Tennessee (Rules of the Tennessee Board of Pharmacy, Chapter 40-0 Introductory Rules, Application for Pharmacy Practice Site, Manufacturer, Outsourcing Facility, Oxygen Supplier and Wholesaler/ Distributor Licenses) As outsourcing facility Other: Must register and possess a modifier as a sterile manufacturer with the Board of Pharmacy $55 $55 biennially Continued on next page 56

47 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed Texas (Health and Safety Code, Chapter 483, Texas Dangerous Drug Act, section ) Other: In-state as prescription drug manufacturers, and out-of-state as prescription drug distributors There is a range based on cross annual sales. $,080-$,95 for a two-year license Same Utah (Class C Pharmacy as defined in UCA 58-7b-0) Other: Must license a Class C Pharmacy as defined in UCA 58-7b-0 () $00 + fingerprinting fee $03 biennially Vermont No Virginia (Commonwealth of Virginia, Chapter 0 Regulations Governing the Practice of Pharmacy, Part VII. Prescription Order And Dispensing Standards, 8VAC Outsourcing facilities and Chapter 34 of Title 54. of the Code of Virginia, The Drug Control Act, Permit to act as an outsourcing facility and Nonresident outsourcing facilities to register with the Board) As pharmacy (if facility compounds patient-specific prescriptions) As outsourcing facility $70 $70 annually Washington West Virginia (RCW Manufacturer s license Fees Display Declaration of ownership and location Penalties. And RCW Wholesaler s license Required Authority of licensee Penalty Ephedrine / pseudoephedrine / phenylpropanolamine) (Application for License Permit or Renewal as a Manufacturer) As manufacturer As wholesale distributor Manufacturer $590 Wholesaler $590 As manufacturer $500 $500 annually Wisconsin No Continued on next page 57

48 License or register facilities that register with FDA under the federal outsourcing facility category of drug compounders Type of licensure or registration License or registration fee Initial fee Renewal fee Pending legislation or regulation and what it would do if passed Wyoming (Unspecified) As pharmacy (if facility compounds patient-specific prescriptions) As manufacturer Unspecified Unspecified License or register facilities that register with the FDA under the federal outsourcing facility category of drug compounders as outsourcing facilities 58

49 Table C.4 Inspections of In-State 503A Pharmacies That Perform Sterile Compounding for Humans Frequency of routine inspections Specific circumstances that trigger inspections Alabama At least every two years Alaska Unsure Unsure Arizona Arkansas California Colorado At least every 8 months At least every 8 months At least every year At least every year Other: Every six months for high-risk sterile Other: Routine approximately annual inspections Other: Also inspect any new locations if a pharmacy moves Licensure renewal Other: Unannounced annual and every six months for highrisk sterile Connecticut Unsure Unsure Delaware District of Columbia Florida At least every year At least every year At least every year Licensure renewal Licensure renewal Other: Damaged premises shall be inspected by the mayor to determine their continued suitability for pharmacy operations Licensure renewal Continued on next page 59

50 Frequency of routine inspections Specific circumstances that trigger inspections Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine No specific frequency No specific frequency Other: There is not a rule in which any facility be inspected. However, it is the intent that every drug outlet be inspected every 8 months. No specific frequency At least every three years No specific frequency At least every year At least every year At least every year At least every year Other: Agents discretion; registrants request Other: Random inspections Licensure renewal Licensure renewal Licensure renewal Continued on next page 60

51 Frequency of routine inspections Specific circumstances that trigger inspections Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska At least every year At least every year No specific frequency Other: Working with the National Association of Boards of Pharmacy (NABP) to look at establishing a plan to inspect on a frequent basis, and using NABP s universal inspection form for sterile compounding. At least every two years At least every 8 months At least every year At least every year At least every five years Licensure renewal Licensure renewal Other: Routine inspections and may inspect if requested by the board or if the risk level of activity changes Other: Change in ownership Other: Random sample of pharmacies inspected annually Continued on next page 6

52 Frequency of routine inspections Specific circumstances that trigger inspections Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania At least every year At least every year At least every 8 months At least every two years No specific frequency Other: Depends on the risk level of compounding annually for high-risk; biennially for medium-risk; at least every four years for low-risk (though frequency typically greater) At least every year At least every year At least every year At least every year At least every year Licensure renewal Other: Whenever board requests Other: No specific circumstances (other than annual inspections) Other: If the pharmacy is due for an inspection under the inspection policy Other: No specific circumstances (other than annual inspections) Other: Routine annual inspections Other: Random inspections Continued on next page 6

53 Frequency of routine inspections Specific circumstances that trigger inspections Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia No specific frequency At least every two years At least every year At least every year At least every two years No specific frequency At least every two years At least every two years At least every two years Other: For pharmacies shipping out-of-state, every 8 months. All others are inspected every two years. Other: Random inspections Other: Yearly inspection schedule Licensure renewal Licensure renewal Other: Random inspections Other: Every 4 months Continued on next page 63

54 Wisconsin Wyoming Frequency of routine inspections No specific frequency At least every year Specific circumstances that trigger inspections Licensure renewal 64

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56 Table C.5 State Oversight of Out-of-State 503A Pharmacies That Perform Sterile Compounding for Humans Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Alabama Other: Unspecified No Alaska Standards of the state where the pharmacy is located (At least every two years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party Other: Verified Pharmacy Program inspection Arizona Standards of the state where the pharmacy is located (Other: Based on home state inspection schedule) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Arkansas Same standards as in-state pharmacies No California Same standards as in-state pharmacies (At least every year) California Colorado Same standards as in-state pharmacies and standards of the state where the pharmacy is located (Other: Applicants are required to submit proof of inspection by resident state pharmacy board) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: A board-approved third-party entity that inspects pharmacy outlets Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Connecticut Same standards as in-state pharmacies (No specific frequency) Other: If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the most recent USP <797>, as amended from time to time, such nonresident pharmacy shall provide satisfactory proof to the department that it is in compliance with the standards required in the most recent USP <797> as amended from time to time Delaware Other: Unspecified (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located District of Columbia Standards of the state where the pharmacy is located (Other: Inspection report required for initial registration and pharmacy is required to report any actions taken by a state regulatory body) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Continued on next page 66 67

57 Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Florida Georgia Same standards as in-state pharmacies Same standards as in-state pharmacies and standards of the state where the pharmacy is located (At least every two years) Other: If the applicant is unable to submit a current inspection report conducted by the regulatory or licensing agency of the state, territory, or district in which the applicant is located, due to acceptable circumstances, as established by rule, or if an inspection has not been performed, the department shall: conduct, or contract with an entity to conduct, an onsite inspection; accept a current and satisfactory inspection report, as determined by rule, from an entity approved by the board; or accept a current inspection report from the FDA No Hawaii Standards of the state where the pharmacy is located No Idaho Illinois Indiana Other: Board may license or register a drug outlet licensed or registered under the laws of another state if the other state s standards are comparable to those in Idaho and acceptable to the board, evidenced by an inspection report Other: Unless there is a direct conflict between Illinois pharmacy law and the pharmacy laws of the state in which the nonresident pharmacy is located, nonresident pharmacies shall abide by all Illinois laws and rules when filling prescriptions for Illinois residents Standards of the state where the pharmacy is located (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Other: If the regulatory board or licensing authority of the state in which a nonresident outlet is located fails or refuses to conduct an inspection or fails to obtain records or reports required by the board, upon reasonable notice to the nonresident outlet, the Idaho State Board of Pharmacy may conduct an inspection No (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Iowa Same standards as in-state pharmacies (At least every two years) Other: If the home state licensing authority has not conducted an inspection, the pharmacy may submit an inspection report from NABP s verified pharmacy program, or the pharmacy may submit an inspection report from another qualified entity if preapproved by the board, if the inspection report satisfies all of the other requirements; another option is for the pharmacy to request the inspection be performed by Iowa compliance staff, costs associated with this inspection are assessed to the requesting pharmacy Require out-of-state 503A pharmacies that perform sterile compounding for humans to comply with the same standards as in-state pharmacies Kansas Other: Unspecified (Other: Must provide a yearly inspection from their home state on renewal) Other: Unspecified Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected at least every year by Kansas, the regulatory or licensing agency of the jurisdiction in which the pharmacy is located, third party Continued on next page 68 69

58 Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Kentucky Standards of the state where the pharmacy is located (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Louisiana Louisiana Same standards as in-state pharmacies (At least every two years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Other: The nonresident pharmacy must submit inspection reports resulting from inspections conducted by any other state pharmacy licensing agency or any agent thereof, and any inspection reports produced by the FDA or the federal Drug Enforcement Administration Maine Other: Unspecified (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Maryland Same standards as in-state pharmacies (At least every two years) Maryland Other: A designee of the Board; the FDA; or another appropriate state entity which indicates compliance with USP <797> Massachusetts Other: Out-of-state licensure is pending; no requirement at this time No Require out-of-state 503A pharmacies that perform sterile compounding for humans to comply with the same standards as in-state pharmacies Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected at least every year by third party: Proposed plan is to have inspections completed by NABP Michigan Same standards as in-state pharmacies (At least every two years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: NABP Verified Pharmacy Program Minnesota Same standards as in-state pharmacies (At least every two years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Other: An authorized representative of the board, per MN Statute 5.9, for example NABP Verified Pharmacy Program Mississippi Same standards as in-state pharmacies (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Missouri Same standards as in-state pharmacies and standards of the state where the pharmacy is located (Other: Board is in process of promulgating a rule that would require inspections within the last year for new applicants; currently, the board requests inspections within the last year and may request additional information if that timeframe is not met) Other: The applicant s home state, but the board may perform an inspection if deemed necessary or appropriate Montana Same standards as in-state pharmacies (Other: At time of initial licensure for an out-of-state mail-order pharmacy) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Continued on next page 70 7

59 Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Nebraska Other: To be qualified to hold a mail service pharmacy license, a person shall be located and operating in a state in which the requirements and qualifications for obtaining and maintaining a pharmacy license or permit are considered by the Department of Health and Human Services, with the approval of the Board of Pharmacy, to be substantially equivalent to the requirements of the Health Care Facility Licensure Act and the Pharmacy Practice Act related to the practice of pharmacy (Other: At least every five years, based on the most recent inspection conducted by the jurisdiction where the pharmacy is located) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Nevada Nevada Standards of the state where the pharmacy is located (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: Drug Enforcement Administration New Hampshire Same standards as in-state pharmacies (At least every 8 months) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: Other responsible state or national regulatory agency or New Hampshire board of pharmacy-approved third party entity New Jersey Same standards as in-state pharmacies (No specific frequency Other: Board requests that every nonresident pharmacy on initial application or during renewal submits an inspection report demonstrating compliance with USP <797> that is no more than two years old) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: NABP New Mexico Same standards as in-state pharmacies (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: Party recognized by that agency to perform such inspection, or party recognized by the board New York Same standards as in-state pharmacies No North Carolina Same standards as in-state pharmacies and standards of the state where the pharmacy is located (Other: At intervals as required by the home state. This issue is under discussion at the board, however.) Other: The facilities and records of an out-of-state pharmacy shall be subject to inspection by the North Carolina Board of Pharmacy; provided however, the board may accept in lieu thereof satisfactory inspection reports by the licensing entity of the state in which the pharmacy is located; board accepts Verified Pharmacy Program (VPP) inspections performed under the auspices of NABP as well because the personnel are board affiliated and the inspection forms and criteria have been developed by, and are monitored by, the state boards of pharmacy North Dakota Same standards as in-state pharmacies (At least every year) North Dakota Third party: A duly authorized agent of a third party approved by the board which is the NABP Verified Pharmacy Program Continued on next page 7 73

60 Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Ohio Same standards as in-state pharmacies (At least every two years) Third party: A regulatory or licensing agency from another licensing jurisdiction, NABP s verified pharmacy program, Accreditation Commission for Health Care inspection services (a.k.a. ACHC inspection services or AIS), or proof of a current pharmacy compounding accreditation board (PCAB) accreditation provided by the Accreditation Commission for Health Care (ACHC) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Oklahoma Same standards as in-state pharmacies (At least every two years) Third party: Any organization approved by the Oklahoma State Board of Pharmacy Other: The Oklahoma State Board of Pharmacy may conduct on-site periodic routine inspections and investigations during reasonable business hours Oregon Other: Unspecified (Other: When a sterile compounding pharmacy is seeking initial and renewal licensure) Other: Unspecified Require out-of-state 503A pharmacies that perform sterile compounding for humans to comply with the same standards as in-state pharmacies Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected Pennsylvania Standards of the state where the pharmacy is located (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: NABP s Verified Pharmacy Program Rhode Island Same standards as in-state pharmacies No South Carolina Other: Unspecified (At least every two years) Third party: Nonresident pharmacy sterile compounding requirements include submitting a copy of last inspection, by qualified individual, of hoods, buffer, clean and ante areas including ISO classification, particle counts and microbiology South Dakota Standards of the state where the pharmacy is located (No specific frequency Other: Requested within four years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: VPP Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected within four years for renewals by the regulatory or licensing agency of the jurisdiction in which the pharmacy is located. There must be an inspection before a new application can be approved. Tennessee Same standards as in-state pharmacies (At least every two years) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Texas Same standards as in-state pharmacies (At least every two years) Texas Third party: Accreditation Commission for Health Care Inc. (ACHC), NABP, or Superior Laboratory Services Inc. (SLSI) Continued on next page 74 75

61 Quality standards state requires Require to be inspected (Frequency) Who performs the inspections Pending legislation or regulation and what it would do if passed Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Utah Same standards as in-state pharmacies (At least every two years) Third party: Conducted as part of the NABP Verified Pharmacy Program Other: Performed by the state licensing agency of the state in which the applicant is a resident and in accordance with the NABP multistate inspection blueprint program Vermont Same standards as in-state pharmacies (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Virginia Same standards as in-state pharmacies (At least every two years Other: The initial application for a new nonresident pharmacy registration must include a report of inspection conducted within six months of the date the application is received by the board) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Other: If the nonresident pharmacy has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is licensed within the required period, the Virginia Board of Pharmacy may accept an inspection report or other documentation from another entity that is satisfactory to the Board or the Board may cause an inspection to be conducted by its duly authorized agent Washington Standards of the state where the pharmacy is located (Other: Based on the state of residence for the pharmacy) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located West Virginia Other: Every 8 months by NABP Universal Inspection (At least every 8 months) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party Wisconsin Other: Unspecified No Wyoming Standards of the state where the pharmacy is located (No specific frequency) Regulatory or licensing agency of the jurisdiction in which the pharmacy is located Third party: NABP blueprint states, NABP VPP inspections, or the FDA Require out-of-state 503A pharmacies that perform sterile compounding for humans to be inspected by the regulatory or licensing agency of the jurisdiction in which the pharmacy is located; third party: NABP blueprint state inspection, NABP VPP 76 77

62 Table C.6 Other Pending Policy Changes Pending legislation or regulation, and what it would do if passed California Modify existing regulations Montana Changes pursuant to 07 legislation, SB 68 78

63 Endnotes The Pew Charitable Trusts, U.S. Illnesses and Deaths Associated With Compounded or Repackaged Medications, 00 7 (07), The Pew Charitable Trusts, Best Practices for State Oversight of Drug Compounding (06), assets/06/0/best_practices_for-state_oversight_of_drug_compounding.pdf. 3 Pennsylvania Code, Chapter 7. State Board of Pharmacy, accessed Sept. 9, 07, chapter7/chap7toc.html. 4 Kansas Board of Pharmacy, Laws and Regulations, accessed Nov., 07, 5 Massachusetts Office of Health and Human Services, letter to USP Expert Committee, Jan. 3, 06, dph/quality/boards/pharmacy/alerts/public-comment-memo.pdf. 6 Washington State Pharmacy Quality Assurance Commission, Sterile Compounding [USP <797>] Self-Assessment Compliance Checklist, accessed Nov., 07, 7 U.S. Pharmacopeial Convention, General Chapter <800> Hazardous Drugs Handling in Healthcare Settings (Sept. 9, 07), New Hampshire General Court, Chapter Ph 00: Organizational Rules, accessed Aug. 6, 07, state_agencies/ph html. 9 Wyoming Pharmacy Laws, Sterile Compounding: Chapter 7, accessed Aug. 6, 07, Wrtc8MWxoTEZhRlpYTkk/view. 0 The Pew Charitable Trusts, Best Practices for State Oversight. Peter D. Austin, Kieran S. Hand, and Marinos Elia, Systematic Review and Meta-Analysis of the Risk of Microbial Contamination of Parenteral Doses Prepared Under Aseptic Techniques in Clinical and Pharmaceutical Environments: An Update, Journal of Hospital Infection 9, no. 4 (05): 306 8, Amber Vasquez et al., Notes From the Field: Fungal Bloodstream Infections Associated With a Compounded Intravenous Medication at an Outpatient Oncology Clinic New York City, 06, Morbidity and Mortality Weekly Report 65, no. 45 (06): 74 75, gov/mmwr/volumes/65/wr/mm6545a6.htm?s_cid=mm6545a6_w. 3 U.S. Government Accountability Office, Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges (06), 4 The Pew Charitable Trusts, Best Practices for State Oversight. 5 Ibid. 6 U.S. Food and Drug Administration, Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (06), UCM49686.pdf. 7 North Carolina Board of Pharmacy, Consent Order: In the Matter of Deep River Drug, April 8, 0, Disciplinary%0Actions%0-%0PHARMACIES/DeepRiverDrug08944.pdf. 8 Reid Paul, Despite Court Ruling, FDA Still Warning Compounders, Drug Topics, Jan. 8, 007, drug-topics/content/despite-court-ruling-fda-still-warning-compounders. 9 U.S. Food and Drug Administration, Preliminary Recommendations for Aligning Federal and State Regulation of Compounders Registered as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (06), Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCo%0mpounding/UCM50830.pdf. 0 The Pew Charitable Trusts, Best Practices for State Oversight. Ibid. NABP and Pew provide some funding for state inspectors to attend the CriticalPoint LLC training program. Additionally, one of the external reviewers of this report is a principal at CriticalPoint, and another external reviewer teaches a portion of a CriticalPoint hazardous drug course. 3 The Pew Charitable Trusts, Best Practices for State Oversight. 79

64 4 Idaho Administrative Procedure Act, IDPAP 7 Board of Pharmacy, 6, 0, accessed Nov., 07, current/7/00.pdf. 5 National Association of Boards of Pharmacy, "Traning and Resources Support Member Boards' Next Steps to Inspection Blueprint Uniformity and State Collaboration," Innovations 46, no. (07): 8 9, Innovations_January_Final.pdf. 6 The Pew Charitable Trusts, Best Practices for State Oversight. 80

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